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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase i studies still needed?
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A comprehensive review of the pharmacokinetics of approved therapeutic monoclonal antibodies in Japan: Are Japanese phase i studies still needed?

机译：对日本已批准的治疗性单克隆抗体的药代动力学的全面综述：是否仍需要日本一期研究？

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摘要

Ethnic evaluation of the pharmacokinetics and safety of new drugs is required in Japan before implementing bridging or joining global studies. As therapeutic monoclonal antibodies (mAbs) show limited ethnic differences, their pharmacokinetics and safety in Japanese individuals could be estimated from prior non-Japanese studies. Therefore, there is potential to re-evaluate the development program for mAbs in Japan. We reviewed the pharmacokinetics of mAbs approved in Japan. Although some differences had been observed in pharmacokinetics of mAbs between Japanese and non-Japanese populations (mainly Caucasians), these differences were attributed to differences of body weight and/or antigen levels. Moreover, the influential factors can be estimated without conducting regional pharmacokinetic/safety studies. The pharmacokinetics of some mAbs is presumably non-linear and show differences between healthy volunteers and patients because of differences in antigen levels. However, for 10/24 mAbs approved in Japan, Japanese healthy volunteer studies were conducted before the patient studies. Additionally, for the mAbs that showed ethnic differences in pharmacokinetics, the doses selected in subsequent patient studies were the same as the doses approved in the United States. In this review, we discuss new drug development strategies in various regions, and assess the need for regional pharmacokinetics/safety studies before joining global studies.
机译：在实施衔接或加入全球研究之前，日本需要对新药的药代动力学和安全性进行族裔评估。由于治疗性单克隆抗体（mAb）仅显示出有限的种族差异，因此可以通过先前的非日本研究评估其在日本人群中的药代动力学和安全性。因此，有可能在日本重新评估mAb的开发计划。我们回顾了日本批准的单克隆抗体的药代动力学。尽管在日本人群和非日本人群（主要是高加索人）之间已观察到mAb的药代动力学差异，但这些差异归因于体重和/或抗原水平的差异。此外，无需进行区域药代动力学/安全性研究就可以估算影响因素。某些mAb的药代动力学可能是非线性的，并且由于抗原水平的差异而显示出健康志愿者和患者之间的差异。但是，对于在日本获得批准的10/24 mAb，在患者研究之前进行了日本健康志愿者研究。此外，对于在药代动力学上显示出种族差异的mAb，在随后的患者研究中选择的剂量与美国批准的剂量相同。在这篇综述中，我们讨论了各个地区的新药物开发策略，并在加入全球研究之前评估了对区域药代动力学/安全性研究的需求。

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